Community Hypertension Assessment Trial (CHAT)

September 19, 2005 updated by: Hamilton Health Sciences Corporation

A Pragmatic Trial of Community Pharmacy Blood Pressure Clinics Linked With Family Medicine Practices to Improve the Monitoring and Management of High Blood Pressure Among Older Adults

The Community Hypertension Assessment Trial (CHAT) is an investigation of the effect of community pharmacy based blood pressure (BP) monitoring sessions led by peer health educators, with feedback to family physicians, on the monitoring and management of blood pressure among older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypertension affects about 22% of Canadian adults and is a modifiable risk factor for cardiovascular disease. Most countries have increasing older adult populations and hypertension prevalence increases with age. However, the "rule of halves" still applies in many primary health care settings: half of the hypertensive patients are undiagnosed, half of the diagnosed patients are untreated, and half of the treated patients are uncontrolled.

Family physicians were randomly selected and approached to participate in CHAT. Paired cluster randomization was used, with practices as the unit of randomization. Data on blood pressure (BP) readings in the last year, diagnosis of hypertension, diagnosis of diabetes and/or target organ damage, and a current antihypertensive profile was extracted from the health records of 55 patients randomly selected in each practice. In practices allocated to the Intervention group, physicians sent a letter, with assistance from research staff, to invite all of their eligible patients 65 years and older to attend one or two BP sessions in nearby pharmacies. Inclusion criteria required that patients be regular patients in the practice, community-dwelling, and mobile/well enough to attend community sessions.

Public health authorities trained older adult volunteer peer health educators to assist patients at the sessions to accurately measure their BP using a validated automated device, and record BP readings and cardiovascular risk factors. The volunteers provided education about hypertension but did not perform a clinical function. A recommendation protocol ensured that the pharmacist and, if necessary, the physician was notified if patients had a very high BP or a very low BP accompanied by symptoms. A public health nurse was 'on-call' during the sessions in case clinical advice was needed. A volunteer coordinator facilitated the transfer of readings and patient-reported cardiovascular risk factors to physicians.

Accurate BP readings were obtained from the BPM-100 automated BP measuring device. Questionnaires were used to obtain self-report data on cardiovascular disease risk factors from patients, knowledge and attitudes about BP control from physicians, and attitudes and satisfaction with the program from peer health educators, pharmacists, and public health nurses.

The primary outcome measure followed an 'intention to treat' approach. The primary endpoint was the difference in the change from 12 months pre- to 12 months post-intervention in the proportion of eligible patients with a BP reading recorded in their health record with mean systolic <=140 mm Hg or mean diastolic <=90 mmHg; <=130 or <=80 if target organ damage or diabetes is present.

This trial is a collaboration by the Department of Family Medicine, McMaster University and the Elisabeth Bruyère Research Institute, a University of Ottawa and SCO Service Partnership.

Study Type

Interventional

Enrollment

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

28 family physicians were recruited; all eligible patients in practices allocated to the intervention arm were invited to the program. A randomly selected set of 50 charts per practice were audited, regardless of session attendance.

Physician Practices

Inclusion Criteria:

  • Non-academic (none of its members are full-time faculty members)
  • Full-time
  • Regular family practice in terms of size and case-mix
  • Able to provide an electronic roster that includes a mailing address of their patients 65 years and older

Exclusion Criteria:

  • work in walk-in clinics or emergency departments
  • about to retire
  • work part-time
  • fewer than 50 patients 65 years or older
  • specialized practice profile

Patients

Inclusion Criteria:

  • Community-dwelling
  • 65 years or older
  • Visited the practice at least once in the last year
  • Considered regular patients by the physician

Exclusion Criteria:

  • Terminally ill
  • Scheduled to have surgery during the program period
  • Not mobile to visit the pharmacy
  • Non-English-speaking and unable to attend with an English-speaking companion
  • Significant cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Difference in the change from baseline to 12 months exit
Assessment in the mean percent of patients with adequate
Assessment / blood pressure (BP) control in intervention compared to control practices

Secondary Outcome Measures

Outcome Measure
Percent of patients with mean BP 140-159 / 90-99
Percent of patients with mean BP 160-179 / 100-110
Percent of patients with mean BP >180 / >110

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

University of Ottawa

Investigators

  • Principal Investigator: Janusz A Kaczorowski, PhD, McMaster University
  • Principal Investigator: Larry W Chambers, PhD, Bruyere Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion

January 1, 2005

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2005

Last Update Submitted That Met QC Criteria

September 19, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0517-149-02
  • CIHR MOP 57902
  • McMaster CSD 2001HO4527

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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